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NCT06307613 · ClinicalTrials.gov registry record · Phase 3
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease
A Phase 3 study, sponsored by argenx.
- Terminated
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT06307613: Clinical Trial Phase 3 study, sponsored by argenx.
NCT06307613 is a Phase 3 study that was terminated before completion, run by argenx. The registered enrollment target is 102 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06307613, a Phase 3 study, was terminated before completion, sponsored by argenx.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks. An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307626). This study was terminated early on 15 December 2025 as the pre-defined interim analysis concluded that continuing the trials is unlikely to demonstrate the intended efficacy. This decision is not related to safety concerns, and the safety profile of efgartigimod remains unchanged. End-of-study and Safety-Follow-Up visits are ongoing for the participants of this trial.
Interventions
- COMBINATION_PRODUCT Efgartigimod PH20 SC
- OTHER Placebo PH20 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2024-03-27 |
| Est. Completion | 2026-02-12 |
| Phase | Phase 3 |
Why NCT06307613 stopped before completion
NCT06307613 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Efgartigimod PH20 SC is the first listed.
NCT06307613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06307613 about?
NCT06307613 is a clinical study titled "A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease". This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After the screening period, eligible participants will be r...
What is the current status of trial NCT06307613?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2024-03-27. Estimated completion is 2026-02-12.
What interventions are being tested in trial NCT06307613?
The interventions under investigation include: Efgartigimod PH20 SC (COMBINATION_PRODUCT), Placebo PH20 SC (OTHER).
Who is sponsoring clinical trial NCT06307613?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06307613's enrollment target sits among peer trials
102 1676th of 2000 higher than 321 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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